check_circleStudy Completed
Hemophilia A
Bayer Identifier:
13401
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial to evaluate the pharmacokinetics and safety profile of BAY94-9027 following single and multiple dose administration
Trial purpose
The purpose of this study is to describe the pharmacokinetics (PK) of BAY94-9027(the test drug). Pharmacokinetics means that we will measure how well the study drug corrects the factor VIII levels in your blood and how long it takes for the levels to fall back to your baseline level. The study is also designed to determine if the pharmacokinetics of BAY94-9027 change following repeat dosing over 8 weeks, determine if BAY94-9027 is safe, tolerable, and effective for the treatment of severe hemophilia A and define the appropriate dose of BAY94-9027. Two doses of BAY94-9027 will be studied.
The first 8 subjects enrolled in the study (cohort 1) will receive a low dose (25 IU/kg) and will be treated 2 days a week for 8 weeks (total of 16 doses). The second 8 subjects (cohort 2) will receive a higher dose and will be treated 1 day a week for 8 weeks (total 8 doses). All subjects will receive a single dose of rFVIII (Bayer Kogenate FS) to determine the PK by measuring blood levels for 2 days before they start the study drug BAY94-9027. Factor VIII blood levels for BAY94-9027 will be measured for 7 days after the first and last dose to see describe the PK. Safety & tolerability assessment include vital signs, coagulation and hematological parameter, clinical chemistry, measurement of FVIII inhibitor and polyethylene glycol (PEG) antibodies will be done during the course of the study.
The first 8 subjects enrolled in the study (cohort 1) will receive a low dose (25 IU/kg) and will be treated 2 days a week for 8 weeks (total of 16 doses). The second 8 subjects (cohort 2) will receive a higher dose and will be treated 1 day a week for 8 weeks (total 8 doses). All subjects will receive a single dose of rFVIII (Bayer Kogenate FS) to determine the PK by measuring blood levels for 2 days before they start the study drug BAY94-9027. Factor VIII blood levels for BAY94-9027 will be measured for 7 days after the first and last dose to see describe the PK. Safety & tolerability assessment include vital signs, coagulation and hematological parameter, clinical chemistry, measurement of FVIII inhibitor and polyethylene glycol (PEG) antibodies will be done during the course of the study.
Key Participants Requirements
Sex
MaleAge
18 - 65 YearsTrial summary
Enrollment Goal
14Trial Dates
October 2010 - October 2011Phase
Phase 1Could I Receive a placebo
NoProducts
Jivi (Damoctocog, BAY94-9027)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Boston, 02115-6195, United States | |
Completed | Syracuse, 13210, United States | |
Completed | Davis, 95616, United States | |
Withdrawn | New Brunswick, 08901, United States | |
Completed | Minneapolis, 55455, United States | |
Withdrawn | New Orleans, 70112-2699, United States |
Primary Outcome
- Safety as assessed by measuring immunogenicityAntibodies to FVIII, polyethylene glycol (PEG) and BAY94-9027date_rangeTime Frame:Up to 8 weeksenhanced_encryptionYesSafety Issue:
- Adverse events collectiondate_rangeTime Frame:Up to 8 weeksenhanced_encryptionYesSafety Issue:
- Area under the plasma concentration vs time curve from time 0 to the last data point (AUC0-tlast)date_rangeTime Frame:Up to 8 weeks
- Area under the plasma concentration vs time curve from zero to infinity after single (first) dose (AUC0-inf)date_rangeTime Frame:Up to 8 weeks
- Maximum drug concentration in plasma (Cmax)date_rangeTime Frame:Up to 8 weeks
- Half-life associated with the terminal slope (t1/2)date_rangeTime Frame:Up to 8 weeks
- Time to reach maximum drug concentration in plasma after single (first) dose (Tmax)date_rangeTime Frame:Up to 8 weeks
- Mean residence time (MRT)date_rangeTime Frame:Up to 8 weeks
- Total body clearance (CL)Total body clearance of drug from plasma (volume/time) or (volume/time/body weight) or ((volume/time)*(1.73/body surface area)) calculated after intravenous administrationdate_rangeTime Frame:Up to 8 weeks
- Apparent volume of distribution at steady state (Vss)Based on the chromogenic, one-stage and PEG capture assaysdate_rangeTime Frame:Up to 8 weeks
- Incremental recovery of FVIIIRecovery was assessed using two different assays (chromogenic and one-stage assay)date_rangeTime Frame:Up to 8 weeks
Trial design
Trial Type
InterventionalIntervention Type
Biological/VaccineTrial Purpose
Basic ScienceAllocation
Non-randomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
2